MAUDE Adverse Event Report: MICROVENTION, INC. FRED-X 27; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FREDX4515-PMA
Medical Device Problem Codes	Structural Problem (2506); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported through the (b)(6) clinical study: the lab reported distal fishmouthing 25-50%, exact percentage is not known.Fishmouthing was observed by the lab on the 6 month follow-up imaging, post detachment.The lab also reported (b)(6) braid bump deformation at the 6 month follow-up imaging.The 6 month follow-up imaging was performed a year prior to the lab reviewing the imaging.Fish-mouthing was also noted by the lab on the 12 month follow-up imaging.There is no planned intervention to address the fish-mouthing.The treatment site during the index procedure is a left supraclinoid aneurysm.Aneurysm is fully occluded (raymond-roy 1).No corresponding adverse event or treatment have been reported for this subject.Subject is waiting for 2 year follow-up visit.
Additional Manufacturer Narrative
A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was implanted and therefore not available for return and investigation by the manufacturer.The alleged product issue/event as described could not be confirmed.

• Brand Name: FRED-X 27
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 24958713
• Report Number: 2032493-2026-00271
• Device Sequence Number: 15975872
• Product Code: OUT
• UDI-Device Identifier: 00842429114391
• UDI-Public: (01)00842429114391
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P180027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Model Number: FREDX4515-PMA
• Device Lot Number: 0000267752
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Race: American Indian Or Alaskan Native